title: An inactivated, adjuvanted whole virion clade 2.2 H5N1 (A/Chicken/Astana/6/05) influenza vaccine is safe and immunogenic in a single dose in humans.
abstract: In this study, we assessed in humans the immunogenicity and safety of one dose (7.5 or 15 μg of hemagglutinin [HA]) of a whole-virion inactivated prepandemic influenza vaccine adjuvanted with aluminum hydroxide. The vaccine strain was made by reverse genetics from the highly pathogenic avian A/Chicken/Astana/6/05 (H5N1) clade 2.2 strain isolated from a dead bird in Kazakhstan. The humoral immune response was evaluated after a single vaccination by hemagglutination inhibition (HI) and microneutralization (MN) assays. The vaccine was safe and immunogenic, inducing seroconversion in 55% of the evaluated patients, with a geometric mean titer (GMT) of 17.1 and a geometric mean increase (GMI) of 3.42 after a dose of 7.5 μg in the HI test against the vaccine strain. The rate of seroconversion increased up to 70% when the dose of 15 μg was used. The percentages of individuals achieving anti-HA titers of ≥1:40 were 52.5% and 57.5% for the 7.5- and 15-μg dose groups, respectively. Similar results were obtained when antibodies were analyzed in an MN test. Substantial cross-neutralization titers (seroconversion in 35% and 52.5% of subjects in the two dose groups, respectively) were detected against heterologous clade 1 strain NIBRG14 (H5N1). Thus, one dose of this whole-virion prepandemic vaccine adjuvanted with aluminum has the potential to be effective against H5N1 viruses of different clades.
authors.affiliation: Research Institute for Biological Safety Problems, Gvardeiskiy, Kazakhstan.
authors.forename: Abylay R
authors.initials: AR
authors.lastname: Sansyzbay
authors.forename: Marianna K
authors.initials: MK
authors.lastname: Erofeeva
authors.forename: Berik M
authors.initials: BM
authors.lastname: Khairullin
authors.forename: Nurlan T
authors.initials: NT
authors.lastname: Sandybayev
authors.forename: Zhailaubay K
authors.initials: ZK
authors.lastname: Kydyrbayev
authors.forename: Seidigapbar M
authors.initials: SM
authors.lastname: Mamadaliyev
authors.forename: Markhabat M
authors.initials: MM
authors.lastname: Kassenov
authors.forename: Maria V
authors.initials: MV
authors.lastname: Sergeeva
authors.forename: Julia R
authors.initials: JR
authors.lastname: Romanova
authors.forename: Vera Z
authors.initials: VZ
authors.lastname: Krivitskaya
authors.forename: Oleg I
authors.initials: OI
authors.lastname: Kiselev
authors.forename: Marina A
authors.initials: MA
authors.lastname: Stukova
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage* / Q000009:adverse effects*; D000328:Adult; D000536:Aluminum Hydroxide / Q000008:administration & dosage / Q000009:adverse effects; D000818:Animals; D000914:Antibodies, Viral / Q000097:blood; D003429:Cross Reactions; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D053124:Influenza A Virus, H5N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D007251:Influenza, Human / Q000517:prevention & control* / Q000821:virology; D007623:Kazakhstan; D008297:Male; D008875:Middle Aged; D009500:Neutralization Tests; D059386:Reverse Genetics; D012426:Russia; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D007252:Influenza Vaccines; D015164:Vaccines, Inactivated; D000536:Aluminum Hydroxide